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Dementia Management With Interactive Technology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03916588
Recruitment Status : Enrolling by invitation
First Posted : April 16, 2019
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Ochsner Health System

Study Description
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Brief Summary:
To investigate the efficacy of an individualized treatment plan delivered through remote technology along with enhanced staff training within a supervised memory unit on patient outcome, care quality, health care utilization/cost, and staff burden. Remote monitoring of activity data will also be explored.

Condition or disease Intervention/treatment
Dementia Memory Disorders in Old Age Behavioral: Individualized Care Plan

Study Design
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Study Type : Observational
Estimated Enrollment : 56 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Dementia Management With Interactive Technology
Actual Study Start Date : August 16, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia Memory

Groups and Cohorts
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Group/Cohort Intervention/treatment
Memory Care Unit Residents
Residents on a locked memory care unit in southeastern Louisiana will be enrolled. Engaged family members and staff will also consent to provide qualitative information on the resident.
 Behavioral: Individualized Care Plan
Medical, neuropsychological, and social assessment of patient's cognitive, behavioral, medical, and environmental needs with a focus on improving quality of life, reducing health care utilization, and improving staff/family caregiving burden along with a specific plan to address and monitor identified patient and staff/facility needs


Outcome Measures
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Primary Outcome Measures :
  1. Mortality/Survival Rate [ Time Frame: through study completion, an average of 1 year ]
  2. Quality of Life Scale (QoL) [ Time Frame: through study completion, an average of 1 year ]
    Neuropsychiatric/behavioral symptoms

  3. Fall Incidence [ Time Frame: through study completion, an average of 1 year ]
    Neuropsychiatric/behavioral symptoms

  4. Zarit Caregiver Burden [ Time Frame: through study completion, an average of 1 year ]
    Family burden

  5. Patient Care Team Burden Scale (PCTB) [ Time Frame: through study completion, an average of 1 year ]
    staff caregiver burden

  6. Healthcare Utilization [ Time Frame: through study completion, an average of 1 year ]
    Number of visits to hospital or clinic


Secondary Outcome Measures :
  1. Fitbit Charge HR activity and sleep data [ Time Frame: through study completion, an average of 1 year ]
    Average daily steps, minutes asleep


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Residents living on the memory care unit will have pre diagnosed advanced dementia or Alzheimer's disease. Subjects will have diminished or no capacity and will require a legally authorized representative.
Criteria

Inclusion Criteria:

  • Residents living in a specific locked memory care unit in Southeastern Louisiana or
  • Family or staff identified as part of the care team of the resident
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916588


Locations
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United States, Louisiana
Ochsner Health System
New Orleans, Louisiana, United States, 70121
Sponsors and Collaborators
Ochsner Health System
Investigators
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Principal Investigator: R. John Sawyer, PhD Ochsner Health System
More Information
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Responsible Party: Ochsner Health System
ClinicalTrials.gov Identifier: NCT03916588    
Other Study ID Numbers: 2018.078
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dementia
Memory Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Neurocognitive Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations